Objective:To discuss the relationship between 18F-FDG PET/CT metabolic parameters and clinical pathological indicators and prognosis in cutaneous malignant melanoma (CMM). Methods:A total of 100 CMM patients (62 males, 38 females, age (56.5±2.5) years) who underwent 18F-FDG PET/CT scans at the Second Xiangya Hospital of Central South University from August 2013 to November 2022 were retrospectively enrolled. Clinical pathological indicators (such as primary site, TNM staging, sentinel lymph node (SLN) status) and metabolic parameters (SUV max, metabolic tumor volume (MTV), total lesion glycolysis (TLG), whole-body MTV (wb-MTV), and whole-body TLG (wb-TLG)) were collected. ROC curve analyses were used to determine the PET parameters thresholds for progression-free survival (PFS) and melanoma-specific survival (MSS). Kaplan-Meier survival analysis, univariate and multivariate Cox proportional hazards regression models were used to analyze the prognosis of patients′ PFS and MSS, and a nomogram survival prediction model was constructed. Results:Results of ROC curve analyses showed that the thresholds of SUV max of primary tumor (p-SUV max), MTV of primary tumor (p-MTV), TLG of primary tumor (p-TLG), wb-MTV and wb-TLG for predicting PFS and MSS were 7.13, 2.24 cm 3, 6.98 g, 2.57 cm 3, 8.04 g and 9.09, 2.34 cm 3, 7.44 g, 2.24 cm 3, 9.17 g, respectively. Results of univariate analysis indicated that several clinical pathological indicators and metabolic parameters were prognostic risk factors for PFS and MSS. Results of multivariate analysis indicated that metastases of SLN (hazard ratio( HR)=2.54, 95% CI: 1.09-5.90; P=0.030) and wb-TLG>8.04 g( HR=2.58, 95% CI: 1.17-5.72; P=0.019) were independent prognostic risk factors for PFS, while metastases of SLN ( HR=4.53, 95% CI: 1.54-13.35; P=0.006) and wb-TLG>9.17 g ( HR=2.48, 95% CI: 1.26-4.89; P=0.009) were independent risk prognostic factors for MSS. A nomogram survival prediction model based on PET metabolic parameter (wb-TLG) and clinical pathological indicator (SLN status) can effectively predict the prognosis of CMM patients. Conclusions:Clinical pathological parameters and PET parameters are associated with the prognosis of CMM patients. SLN status is critical for prognosis.

Objective The applications of personalized abutments and abutment crown bridge products have increased year by year,but there is no clear requirement for clinical evaluation of the same variety of such products.This study mainly introduces the clinical evaluation concerns of personalized abutments and abutment crown bridge products,in order to provide reference for the declaration and registration of such products.Methods The clinical evaluation of personalized abutments and crown bridge products are summarized,and the research content of clinical evaluation is clarified.Results The clinical evaluation requirements that need to be considered by enterprises are introduced.Conclusion Personalized abutment and abutment crown bridge products can refer to this study when they are launched in China,mainly using in vitro performance comparison tests for equivalence verification.

Embolization microspheres can be used for the embolization of hypervascular malignant tumors of parenchymal organs.They can also be used as an adjuvant therapy for surgery to reduce perioperative bleeding through preoperative intravascular embolization of tumors.This study summarizes the clinical guidelines and consensus on embolization microspheres and introduces the guidance document for embolization microspheres issued by the Food and Drug Administration(FDA).Additionally,this study presents the authors'thoughts on clinical review of embolization microspheres,aiming to provide insights for the clinical evaluation and technical review of such products.

Objective:To retrieve, evaluate, and integrate the evidence from both domestic and international sources on the management of artificial airways in children.Methods:All evidence on the management of artificial airways in children, including clinical decisions, evidence-based guidelines, expert consensus, best clinical practice manuals, evidence summaries, systematic reviews and so on was retrieved through computer on UpToDate, Cochrane Library, Joanna Briggs Institute (JBI) Evidence-based Healthcare Center Database in Australia, Guidelines International Network, National Guideline Clearinghouse, American Association for Respiratory Care, PubMed, Medline, CINAHL, China Biomedical Medline Disc, China National Knowledge Infrastructure, WanFang Data, Medlive, and other databases and websites. The search period was from database establishment to April 30, 2022. We evaluated the quality of the included literature, extracted and integrated evidence, determined the level of evidence recommendation.Results:A total of 24 articles were included, including four clinical decisions, six evidence-based guidelines, one systematic review, six expert consensus, one evidence summary, one industry standard, four best clinical practice manuals, and one original study. Finally, 36 recommendations were summarized from five aspects, including artificial airway establishment, airbag management, airway humidification, endotracheal suction and prevention of complication.Conclusions:Artificial airway management in children is crucial for the treatment of critically ill children. The summary of the best evidence can provide a theoretical basis for the standardized management of artificial airways in children.

Objective:To investigate the effect of 18F-FDG combined with 18F-prostate specific membrane antigen (PSMA)-1007 PET/CT on TNM staging and clinical treatment decision of patients with prostate cancer. Methods:Clinical data and PET/CT images of 31 patients (age (69.9±9.2) years) with prostate cancer who underwent PET/CT imaging with 18F-FDG and 18F-PSMA-1007 (dual-tracer imaging) in the Second Xiangya Hospital of Central South University from June 2020 to March 2022 were retrospectively analyzed. Paired χ2 test was used to compare the diagnostic efficacy of 18F-FDG, 18F-PSMA-1007 and combined imaging for diagnosing primary prostate cancer, regional lymph node metastases and distant metastases, and to analyze the influence of combined imaging on clinical treatment decision. Results:There were 282 metastatic sites in 31 patients, including 46 regional lymph node metastases in 13 patients and 236 distant metastases in 15 patients. The detection rates of 18F-PSMA-1007 PET/CT and combined imaging for primary lesions were higher than the detection rate of 18F-FDG PET/CT (100%(31/31), 100%(31/31) vs 64.5%(20/31); χ2=13.37, P<0.001). Based on analysis of patients, the detection rates of 18F-PSMA-1007 PET/CT and combined imaging for regional lymph node metastases were higher than the detection rate of 18F-FDG PET/CT (12/13, 12/13 vs 6/13; χ2=4.51, P=0.034), and the 3 detection rates for distant metastases were also significantly different (15/15, 15/15 vs 10/15; χ2=6.00, P=0.042). Based on analysis of lesions, the detection rates of 18F-PSMA-1007 PET/CT and combined imaging for regional lymph node metastases were higher than the detection rate of 18F-FDG PET/CT (95.7%(44/46), 97.8%(45/46) and 45.7%(21/46); χ2 values: 25.37-49.56, all P<0.001). The detection rate of combined imaging for distant metastases was higher than that of 18F-FDG or 18F-PSMA-1007 PET/CT alone (96.2%(227/236) vs 68.6%(162/236), 58.9%(139/236)); and the detection rate of 18F-FDG PET/CT was higher than that of 18F-PSMA-1007 PET/CT ( χ2 values: 4.85-94.22, all P<0.05). Clinical treatment decisions in 10 patients (32.3%, 10/31) were changed based on the results of combined imaging. Conclusion:For prostate cancer with suspected distant metastases, 18F-FDG and 18F-PSMA-1007 dual-tracer PET/CT imaging can improve staging and guide clinical treatment decisions.

From the perspective of technical evaluation, this article introduces the focus of clinical evaluation of dental implants (systems) in comparison with the comparable devices and discusses the clinical evaluation of such products，combined with the clinical evaluation review of dental implants (systems) products in recent years, in order to provide reference for the registration of these products.
Dental Implants

Objective:To explore the clinical characteristics and prognostic risk factors of accidental injuries in pediatric intensive care unit(PICU).Methods:The children with accidental injuries admitted to the PICU at Shanghai Children′s Hospital from January 2017 to December 2019 were analyzed retrospectively.The patients were divided into survival group and death group according to outcome.We collected the patients′ clinical data and laboratory indexes, and analyzed the differences between two groups.Multivariate Logistic regression was used to screen the risk factors of death and receiver-operating characteristic(ROC)curve was used to determine the threshold.Results:(1)A total of 253 children were included, accounting for 5.2% of PICU hospitalization during the same period.There were 137 males(54.2%)and 116 females(45.8%), with an average age of 45(19, 96)months.The top three causes of accidental injuries were fall injury in 82 cases(32.4%), traffic accident in 70 cases(27.7%)and foreign body in 39 cases(15.4%). There were 22 cases of deaths, with a fatality rate of 8.7%.(2)The mean arterial pressure at admission in the death group was lower than that in the survival group( P<0.05), and the total length of stay was longer( P<0.001). There were significant differences in Glasgow coma scale, Pediatric Risk of Mortality Scoring Ⅲ(PRISM Ⅲ)between the two groups( P<0.001). In the death group, and the blood lactic acid(LA) significantly increased( P<0.001), hemoglobin and fibrinogen were lower than those in the survival group, the activated partial thromboplastin time and prothrombin time(PT)were significantly prolonged( P<0.001). (3)Multivariate Logistic regression analysis showed that PRISM Ⅲ score, LA and PT were independent risk factors for the death of accidental injuries.The area under curve(AUC)of PRISM Ⅲ score was 0.987(95% CI 0.976-0.999, P<0.001)and the cut-off value was 11 with a sensitivity of 100% and a specificity of 95.7%.The AUC of LA was 0.886(95% CI 0.810-0.961, P<0.001)and the cut-off value was 3.1 mmol/L with a sensitivity of 85.7% and a specificity of 77.3%.The AUC of PT was 0.835(95% CI 0.730-0.941, P<0.001)and the cut-off value was 13.9 s with a sensitivity of 86.6% and a specificity of 72.7%. Conclusion:The main accidental injuries in PICU of our hospital in the past three years are falling injuries, traffic accidents and foreign body injuries.PRISM Ⅲ score, LA and PT at admission are independent risk factors for predicting death.

OBJECTIVE： To explore the role of clinical pharmacists in medication therapy management （MTM）. METHODS： Referring to the practice model of MTM in the United States， taking a noninfectious chronic disease （obesity diabetes mellitus） patient as an example， clinical pharmacists of endocrinology specialty carried out MTM according to five processes， such as patient information collection， medication therapy review， the formulation of medication-related action plan （MRP）， interventions related to direct communication with physicians or advising patients to consult relevant medical service personnel， record and follow-up. RESULTS： The information of patients collected by clinical pharmacists included past medical history， family history， allergy history and medication history， etc. It was the top priority MRP for this patient to identify inappropriate hypoglycemic drug therapy， obesity-induced obstructive sleep apnea-hypopnea syndrome and hyperlipidemia. For obesity patients with type 2 diabetes mellitus， clinical pharmacists recommend that patients changed insulin drugs to non-insulin drugs， and liraglutide was recommended. In view of the poor control of blood lipid level， fenofibrate was recommended for patients on the basis of oral administration of simvastatin. The patient’s attending physician agreed with the above suggestion and adjusted the prescription. Clinical pharmacists provided medication education for the patients about the importance of each drug， control of total energy intake， balanced diet and physical exercise. The follow-up results after 6 months showed that blood glucose （fasting blood glucose 5-7 mmol/L， postprandial blood glucose 8-10 mmol/L） and blood lipid （total cholesterol 4.80 mmol/L， triglyceride 1.60 mmol/L， low density lipoprotein 3.05 mmol/L） of the patient were effectively controlled and body weight was reduced by 3 kg， but the improvement of lifestyle was poor， mainly due to the nature of his work. Clinical pharmacists once again communicated with him and emphasized the importance of proper physical exercise. The patients agreed to continue the follow-up. CONCLUSIONS： Clinical pharmacists can provide professional consultation and service for patients with chronic diseases by means of MTM service mode， which has certain value for improving medical quality.

OBJECTIVE:To investigate the status quo of knowledge-attitude-practice(KAP)of medication in residents,and to explore potential risk factors that may affect medication. METHODS:By approximate random sampling,online(wenjuanxing)and offline method (5 communities of Chengdu city) were used to collect general information (gender, age, monthly income, residence,medical insurance,education level,working condition,occupation)of the residents aged 19 year-old above and conduct KAP investigation during Jul.-Aug. 2017. Multiple linear regression analysis was used to analyze the influence of residents'general information on KAP. RESULTS:A total of 517 online and offline valid questionnaires were obtained, including 200 offline questionnaires were sent out and 184 valid questionnaires were returned with recovery rate of 92％. Average scores of medication knowledge,attitude and practice were (71.4 ± 32.3),(33.7 ± 14.0),(60.7 ± 19.4),which all reached"good"in the evaluation standard of questionnaire results. The results of multiple linear regression showed that elderly and low education level were the significant influential factors of residents'lack of medication knowledge. The male,elderly,low income and low education level were the influential factors of poor drug use behavior. The residents with poor attitudes towards medication were low income and low educated population. CONCLUSIONS:The average risk of residents'medication in China is low,but it is still necessary to strengthen medication education for special people. It is requisite to focus on the elderly,the low education level,the low income population and the male residents.

Objective To systematically evaluate the optimal dose of early enteral nutrition support in critically ill patients.Methods Systematic search database including PubMed,Web of science,Scopus,CINAHL,CBM,CNKI.RCTs about early enteral nutrition dose selections in critically ill patients were chosen according to include and exclude criteria by two researchers independently.Cochrane system evaluation manual bias risk assessment was used to evaluate quality of literature.RevMan5.3 Meta analysis software was used to analyze the data.Results A total of 1 571 literatures were retrieved and 8 RCT studies were included,2 713 subjects in total.Meta analysis results showed that there were statistically significant differences in mechanical ventilation time,incidence of diarrhea,and utilization rate of gastro dynamic drugs between trophic feeding and full feeding (P＜0.05).There were no statistically significant differences in mortality,length of stay,incidence of nosocomial infections,reflux,vomiting,constipation,etc.(P＞0.05).Conclusions Trophic feeding has familiar effects on mortality,length of hospital stay compared to full feeding,but it can help to shorten ICU mechanical ventilation time,improve the gastrointestinal tolerability.